NIH Design Requirements Manual
Section 2.3
November 27, 2012 Draft
1
2
3
Section 2.3
Animal Research Facility (ARF) Programming
2.3.1 General
4
5
6
7
8
9
10
11
12
13
This section describes planning and programming requirements for animal facilities constructed
for biomedical research at animal biosafety level 2 (ABSL-2) or lower. There are a wide range
of animal facility types including small animal facilities used primarily for rodents, rabbits and
other small mammalian species; large animal facilities used primarily for cats, dogs, sheep,
swine, non-human primates and other mid-sized mammalian species; farm animal facilities,
breeding facilities, and others. This document focuses on small and large animal facilities
which comprise most projects constructed for the NIH.
For laboratory planning and
programming, reference Section 2.1 (link). For ARF specific requirements, abide by this
section. Additional requirements for facilities supporting ABSL-3 research are included in
Sections 2.5 and 2.6.
14
15
16
17
18
19
20
NIH animal facilities shall be planned to ensure the welfare of both research animals and facility
staff. Research facilities requiring animal use shall conform to The Guide for the Care and Use
of Laboratory Animal, 8th edition (the guide). Conformance with this standard is required for
accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care
International (AAALAC). Another primary standard used by AAALAC to evaluate animal care
and use programs is the Guide for the Care and Use of Agricultural Animals in Research and
Teaching (Ag Guide).
21
22
23
Animals shall not be housed in laboratories or spaces other than approved animal housing
facilities for periods exceeding 24 hours unless the area is established as a satellite animal
housing facility.
24
25
26
27
28
29
30
31
The NIH requires an integrated planning and design process which seeks the active and
continuing participation of all stakeholders who are affected by the project from planning through
activation and operation. A list of stakeholders to be involved is included in Section 2.1.1.
Additional stakeholders that must be included for animal facility projects are veterinary, animal
care and animal facility management staff. These individuals are the primary users and may
reside within the facility. Investigators utilizing research animals housed within the facility may
also need to be included to gain an understanding of research-specific procedures, equipment,
and protocols that may affect facility design.
32
2.3.2
33
34
35
36
37
38
39
40
41
Research animal facilities are process-driven workplaces. Material flow and standard operating
procedures inform planning and design. Programming requires a thorough understanding of the
specialized processes and activities to be conducted. Designers must verify the specific animal
species to be housed, special procedures in place to ensure animal health and research
integrity, animal husbandry processes and other factors that impact requirements. ARFs may
be designed for small animals, large animals or a mix of species. Other specialized functions
may include aquatics holding, insectaries and other less common animal models. Facilities shall
be generically planned with the flexibility to accommodate multi-species housing to the greatest
extent possible.
ARF Programming
Page 1
NIH Design Requirements Manual
Section 2.3
November 27, 2012 Draft
42
2.3.2.1 Project Parameters
43
44
45
46
47
Program development shall include identification of limitations and constraints that frame the
project scope. The design team shall identify limitations during the programming phase so the
challenges may be addressed appropriately in the design phase. Specific areas to be
investigated are identified in section 2.1.2.1. Additional areas of concern for animal facilities are
as follows:
48
49
50
51
a) Infrastructure: Utility services serving animal facilities require enhanced performance for
dependability, control, airflow and redundancy. Infrastructure that is suitable for
laboratories may not meet the requirements for animal facilities. Refer to engineering
sections for further information.
52
53
54
55
56
b) Schedule and Phasing: Expanding or renovating existing, functioning animal facilities
requires special consideration to ensure that ongoing operations are not disrupted or
compromised since a variety of animal species are intolerant of noise and vibration.
Utility outages are also problematic since research animals should not be exposed to
environmental fluctuation and cannot be easily moved.
57
2.3.2.2 Data Collection
58
59
60
61
62
63
64
A needs assessment shall be conducted, starting with completion of the ARF Program
Questionnaire. (link). The program questionnaire collects data on the general mission of the
animal facility, species and quantities to be housed, animal health status, biosafety level(s),
existing and projected staffing, procedure space requirements, equipment requirements,
standard operating procedures, storage needs, and use/storage of hazardous chemicals,
biologics, and radiologicals. Specific data to be collected is identified in section 2.1.2.2 (as
applicable), supplemented as follows:
65
a) User Questionnaire: An ARF-specific questionnaire shall be completed by users. <LINK>
66
67
68
69
70
b) Animal Census: Quantity and species of resident animal colonies and their attendant
caging requirements are primary factors affecting facility design. Caging may be fixed or
mobile, static or ventilated. Cage size is governed by the guide as well as specific
research protocols. Caging may be cleaned in place or require special laminar flow
containment equipment for change-out and animal transfer.
71
72
73
74
75
c) Animal Health Status: Research animals are often purpose-bred and certified to be free
of specific pathogens that can be transmitted to other animals or affect research
outcomes. Specific Pathogen Free (SPF) animals require special handling procedures to
ensure that their health status is not compromised. SPF animals may also need to be
housed in barrier facilities separated from conventional, non-SPF animals.
76
77
78
79
d) Equipment: Animal facilities equipment typically includes caging, cage sanitation and
decontamination equipment, procedure room equipment including biosafety cabinets,
treatment tables and lights, surgical equipment, etc. An equipment schedule shall be
used to collect the data, supplemented with manufacturer data sheets that identify
Page 2
NIH Design Requirements Manual
Section 2.3
November 27, 2012 Draft
80
81
82
83
84
85
86
87
88
89
90
91
92
93
94
95
variability in size, service clearances, utility demands, heat output, etc <LINK TO
SCHEDULE>.
e) Standard Operating Procedures: Facility design and operating procedures are
interdependent, and incomplete understanding of SOPs often results in functional design
deficiencies. Every effort shall be made during the programming phase to document
SOPs that have a direct affect on design. These include, at a minimum:
 Use of personal protective equipment (PPE)
 Entry and exiting procedures for different zones within the facility
 Cage handling and sanitation procedures
 Decontamination procedures (waste, space, caging, animal carcasses and
material)
 Security protocols
 Feed, bedding and animal drinking water use, storage and disposal
 Animal intake and quarantine procedures
 Emergency management procedures
 Maintenance and repair procedures
96
2.3.2.3 Data Recordation
97
Comply with section 2.1.2.3. Additionally, record SOPs in either narrative or flow chart format.
98
2.3.3 ARF Planning
99
2.3.3.1 Location Considerations
100
101
102
103
104
105
106
107
108
109
Several factors should be considered in locating the ARF within a research building. Since
these facilities typically require access to loading docks and heavy use of water prone to
leakage to lower levels, a lower level location may be optimal. Other factors that may affect
facility location include:
 investigator access
 animal transport
 security and intrusion protection
 environmental issues (odors, vibration, noise)
 utility maintenance access
 material handling
110
111
There may also be risk factors such as natural hazard mitigation and biosafety that should be
considered to establish acceptable locations for the ARF within a building.
112
2.3.3.2 Space Requirements
113
114
115
116
Calculating optimal size for a vivarium begins with determining the animal holding capacity and
procedure space requirements. These functions typically occupy approximately 50% of the
overall net usable area for facilities operating at ABSL-2 or lower. Other functions will include
sanitation (cage wash, decontamination), animal health (treatment, surgery, quarantine),
Page 3
NIH Design Requirements Manual
Section 2.3
November 27, 2012 Draft
117
118
personnel support (office, break) and logistics (loading dock, receiving, storage). The following
chart illustrates proportional net space allocation for typical facilities.
119
120
121
122
123
This rule of thumb does not take into account special functions that may be incorporated such
as advanced animal imaging, research-specific procedure rooms, isolation suites for barrier
colonies, biocontainment suites, etc. Factors that affect animal holding and procedure space
requirements are listed in section 2.4.5
124
2.3.3.3 Contamination Control
125
126
127
128
129
130
131
132
133
Layout, engineering controls and SOPs play a coordinated role in controlling the spread of
infection within research animals housed in a facility. Animals, materials and personnel can be
characterized as “clean” or “dirty”, referring to their potential for transmitting diseases to resident
animals. For example, animals from an unapproved source are considered “dirty” until they
have been evaluated for health status during a quarantine period. Feed, bedding and other
incoming materials may also be considered “dirty” until decontaminated. Animal bedding and
caging that is soiled from use may be considered “dirty” until it has been sanitized. Staff must
also follow designated SOPs for gowning, hand wash, and circulating through the facility to
minimize opportunities for cross contamination.
134
135
136
137
138
139
140
141
142
143
144
Areas of the animal facility that are prone to contamination and need to be protected by
contamination control SOPs are located within a contamination control “Barrier”. Typically,
these areas comprise animal holding and procedure rooms as well as animal support areas
where caging is cleaned and decontaminated and “clean” expendable materials used within the
facility are stored. The barrier is defined as the assembly of partitions, floors and ceilings that
encapsulate this area. Personnel entering into the barrier must gown per established SOPs.
Material entering into the barrier must be decontaminated. Anterooms typically afford access in
and out of the barrier so that directional airflow can be maintained and gowning SOPs
facilitated. Circulation of animals, materials, personnel and waste within the barrier should be
configured to move from cleaner towards dirtier areas of the facility whenever possible to
minimize opportunity for contamination.
145
146
147
In some facilities, additional suites are located within the overall vivarium barrier that require
enhanced protection or containment. The perimeters of these suites are also protected by
barrier-type enclosures and subject to additional SOPs and directional airflow.
148
Page 4
NIH Design Requirements Manual
Section 2.3
November 27, 2012 Draft
149
2.3.3.4 Functional Relationships
150
151
152
153
154
155
156
The zones within an animal research facility include animal holding and procedure, vivarium
support, personnel support, and logistics. Grouping compatible functions within their respective
zones enhances contamination control and facilitates workflow. Circulation pathways between
zones should be designed to facilitate directional movement of “clean” and “dirty” materials,
animals, caging, waste, and personnel. The HVAC design must also be coordinated with the
zoned planning approach to facilitate directional airflow from cleaner to dirtier areas. The
following diagram illustrates the relationship among typical animal facility zones:
157
ARF Typical Relational Diagram
Barrier
Lockers/
Gowning
Holding / Procedure Zone
e
Lockers/
Gowning
e
Visitors
& Staff
Animal
Holding &
Procedure
Personnel Zone
Admin
Offices
Personnel
Support
(Lockers &
Gowning)
Ante
Room
Ante
Room
Clean
Cage
Wash
Soiled
Cage
Wash
Loading
Dock &
Storage
Animals
&
Supplies
Waste
Logistics Zone
Access Control
Circulation
Vivarium Support Zone
Zone
158
159
160
161
162
163
164
165
166
The Project Officer and the Programmer shall work with the facility representatives to prepare
functional and adjacencies flow charts that will facilitate the design process. Adjacencies shall
be planned to facilitate operational procedures, enhance contamination control and maintain
zonal relationships. Proper arrangement of critical adjacencies enhances the process of animal
based science, improves the quality of life of the animals, and facilitates animal caretaking
SOPs. Appropriate adjacency planning also helps isolate noise and vibrations, economize
circulation routes, and simplify facility operations.
167
a) Personnel Support Zone
168
169
170
171
172
The personnel support zone includes an administrative office area serving the facility
manager, administrative staff, and technician cubicles where staff wear street clothes. It
may also include a veterinarian office and conference/training room. This area should be
located to serve as a “gateway” into the ARF, so that incoming staff, visitors and
investigators can be received or observed prior to entering secure areas of the facility. The
Page 5
NIH Design Requirements Manual
Section 2.3
November 27, 2012 Draft
173
174
175
176
177
178
179
180
181
182
183
personnel support zone is categorized as “dirty” because there is limited control of potential
contaminants in this area. Toilet / locker / gowning areas serve as a transition into the
barrier, and should be located between the administrative area and the facility barrier.
Gowning vestibules for donning PPE may be separate from the toilet / locker / shower room,
and must be provided with sufficient floor area for PPE storage racks and disposal bins so
as not to obstruct required circulation and egress paths. A break room is required for facility
staff to use for consumption of food outside the barrier. In some cases, it may be
appropriate to locate a staff write-up area and break facility within the barrier for caretaker
convenience, but this requires special SOPs and must be approved by the veterinarian and
facility manager. Separate toilet / shower / locker facilities are required for men and women,
except in very small facilities.
184
b) Animal Holding and Procedure Zone
185
186
187
188
189
190
191
192
The animal holding and procedure zone is considered to be a “clean” area located within the
barrier. Personnel entering this area must be gowned using PPE established by SOP.
Material entering this area must be decontaminated per SOPs. Clean caging enters this
area after sanitation in the cage wash area. Soiled caging is returned to the cage wash area
via a separate pathway, or along the same path utilizing a movement/timing pattern that
minimizes cross contamination between clean and soiled items. Animal holding and
procedure spaces are often comingled so that animals do not need require excessive
transport.
193
194
195
196
197
198
199
200
Procedure space may be general, shared rooms designed for generic procedures or highly
specialized space customized for specific uses. In some cases, the program may require
dedicated procedure rooms interconnected with the holding rooms they serve. Specialty
procedure functions may include surgical rooms or suites, behavioral suites, animal imaging
rooms, irradiation rooms, and other purpose-built areas. The number of required procedure
rooms varies in accordance with species, equipment needs, and animal transport
restrictions, however, sufficient generic procedure space should be provided to ensure
flexibility for both current and future research initiatives.
201
c) Vivarium Support Zone
202
203
204
205
206
207
208
209
210
211
212
213
214
The primary activity within the vivarium support zone is cage processing including cleaning
and decontamination of caging and caging accessories, soiled bedding removal, and
preparing caging for return to animal holding rooms. Many of these activities occur in the
cage wash area, which shall be divided with a dirty side for incoming soiled caging and a
clean side for caging that has passed through sanitation equipment. Facilities housing SPF
animals may also require a sterile caging area adjacent to clean cage wash for caging setups that have been autoclaved. Other areas include feed and bedding storage, clean cage
storage, and diet kitchen for large animal facilities that prepare fresh feed. Soiled caging
and waste shall be routed along separate pathways than clean material and caging to the
greatest extent possible. If separate clean and dirty circulation cannot be fully achieved, a
single corridor may be utilized with one-way circulation or time separated clean and dirty
use. Cage processing SOPs must be confirmed by veterinary and caretaker staff, and
proposed SOPs must be described.
215
216
217
Other vivarium support zone functions may include quarantine, rederivation and other
functions related to bringing animals from unknown sources into the barrier or reintroducing
animals after they have been removed from the barrier. Location of quarantine functions
Page 6
NIH Design Requirements Manual
Section 2.3
November 27, 2012 Draft
218
219
outside of the barrier should be considered. Cage decontamination and transport from
quarantine areas should be managed to maintain contamination control.
220
d) Logistics Zone
221
222
223
224
225
226
227
228
229
230
231
232
233
234
235
The logistics zone includes the loading dock, receiving area vertical transport from the
loading dock to the animal facility, medical pathological waste (MPW) storage freezers or
cold room, and storage space for cage wash detergents, disinfectants and other material. In
larger facilities, automated bedding dispensing and waste soiled bedding removal
equipment may also require space. Areas associated with the loading dock are considered
to be an extension of the vivarium and shall be separated from general building logistical
areas to the greatest extent possible. Ideally, they should connect directly to the vivarium.
When direct connection is not possible, a dedicated pathway for transport of animals,
materials and waste shall be defined. They shall be designed to promote proper sanitation
and resist pest infestation. The loading dock area accessing the dumpster and waste
disposal operations should be separated from the animal and material receiving area. Large
animal facility truck bays should be configured to allow vehicles to enter a screened,
sheltered off-loading area, or otherwise dock to the receiving area. The pathway between
receiving and the barrier shall include a vestibule or anteroom for decontamination of
incoming materials. Finishes and detailing shall facilitate sanitation and pest management
236
2.3.3.5 Circulation
237
238
239
240
241
242
243
244
245
246
247
Circulation pathways are critical for facilitating operations and enhancing contamination control
within the animal research facility. Planning of circulation focuses on the movement of
personnel, cages, racks, materials, and waste through the facility. During the planning phase
the design team must work with the facility manager and veterinarian to determine the extent to
which the corridor system and SOPs governing time and direction of movement can
accommodate clean and dirty circulation. Personnel, equipment and supplies shall move from
areas of least contamination to areas of greater contamination. Movement of personnel,
equipment and supplies shall be planned to minimize the potential for contamination of cleaner
areas. Consideration shall be given to provision of space for staging clean and soiled caging
and materials as well as space for personnel gowning and gown removal. Movement of
sterilized materials into barrier suites must also be considered.
248
249
250
251
252
253
254
255
256
a) Corridor Width: Corridor width shall be dependent on the flow of traffic and cage staging
requirements within the animal facility. The Guide recommends a corridor width of 1 825
mm (6’-0”) – 2 450 mm (8’-0”). Two animal cage racks or pieces of the largest mobile
equipment must be able to pass each other without restriction in the corridor. Minimum
corridor width of 7’-0” is recommended for NIH facilities provided that this allows for twoway cage passage clear of wall protection rails (typically protruding 3” from each wall).
Sufficient storage shall be provided within the facility so that caging and equipment does
not have to be stored in the corridors. Marshalling alcoves for racks and carts shall be
provided in congested areas so that corridors are not obstructed by equipment.
257
258
259
260
261
b) Vertical Transportation: In multilevel facilities, dedicated clean and dirty animal elevators
are required. The elevator for transporting clean material shall be located near the clean
side of the cage wash area, while the elevator used for soiled material shall be in close
proximity to the soiled side of the cage wash area. Refer to Section 4.10, Vertical
Transportation for additional ARF elevator requirements. <LINK>
Page 7
NIH Design Requirements Manual
Section 2.3
November 27, 2012 Draft
262
2.3.3.6 Workplace Enhancement
263
264
265
Animal facilities are staffed with highly trained and educated personnel who often spend large
portions of their time within an industrial workplace. Maintenance of a safe, ergonomic and
aesthetic work environment is essential.
266
267
268
a)
Functional Zoning: Personnel office areas must be separated from animal and vivarium
support areas. Vivarium equipment that creates excessive noise, heat, or vibration
should also be buffered from normally occupied areas.
269
270
271
272
273
274
b)
Personnel Support: A break room equipped with kitchenette and tables shall be
provided where staff can eat, drink and interact outside of the vivarium environment.
Lockers shall be provided for animal caretakers and technicians to store street clothing
and personal items. Cubicle lockers may also be considered for investigators using the
facility. Showers are also required in any facility that includes cage wash, and as
stipulated by SOPs.
275
276
277
278
279
280
c)
Natural Lighting: Natural lighting and exterior views should be provided in office areas,
break rooms, and other areas normally occupied areas outside of the barrier to the
greatest extent possible. Natural lighting shall not be provided within holding and
procedure areas unless specifically approved by the facility manager, veterinarian and
security officer. Corridors and support vivarium support functions within the barrier can
also benefit from natural lighting if there are not specific reasons preventing it.
281
2.3.3.7 Flexibility
282
283
284
285
Animal facilities require flexibility to meet fluctuating research needs. Flexibility is also needed
to incorporate changing technologies in scientific procedures and instrumentation, and
accommodate functional use changes without disrupting mission-critical functions. The
following planning concepts can maximize flexibility:
286
287
288
289
290
a) Generic Design: The animal facility shall be flexible and adaptable to accommodate
changes in function and protocols without having to make major changes to the facility.
Spaces should be designed to hold multiple species over time as protocols change.
Individually planned or customized spaces are to be avoided. Animal holding and
procedure rooms shall be designed to allow for interchangeability.
291
292
293
294
295
b) Modularity: Significant portions of animal facilities comprising holding and procedure areas
can be organized in a modular pattern that supports a variety of caging types and layouts.
Modularity shall extend to utility delivery systems. Modular distribution arrangements shall
allow individual areas to be shut down for alteration or repair without impacting utility
delivery to adjacent areas.
296
297
298
299
c) Furnishing Systems: Vivarium furnishing systems shall be flexible and, where practical,
movable to allow for reconfiguration of benches and instrumentation without major
renovation. Modular systems shall be utilized that permit interchangeability of components
or substitution of equipment for bench elements.
Page 8
NIH Design Requirements Manual
Section 2.3
November 27, 2012 Draft
300
301
302
303
d) Utility Systems Flexibility: Components of the utility infrastructure and distribution system
that require routine maintenance should be accessible without requiring entry into the
barrier or disruption of day-to-day operations. Distribution modes shall allow individual
areas to be shut down for alteration or repair without major disruption to adjacent areas.
304
305
e) Expansion: Planning analysis shall include consideration for future expansion of the animal
facility without disruption to the operational facility.
306
2.3.3.8 Utility Systems:
307
308
309
Utility systems serving animal research facilities shall be designed to maintain stable
environments, flexibility to accommodate changing demands, redundancy to insure
dependability, and accessible for maintenance without disrupting operations.
310
311
312
313
314
a) Maintenance Accessibility: Utility system mains and components requiring service or
periodic adjustment should be located in areas that allow for alteration and adjustment
without entry into the animal areas to the maximum extent practicable. Branch services
shall be extended to individual spaces on a modular basis so that individual rooms can
be isolated with minimal disruption to adjacent spaces.
315
316
317
318
319
320
321
There are numerous design strategies that facilitate maintenance accessibility including
provision of an interstitial floor above the animal facility, utility corridors, saddlebag
mechanical rooms, etc. Some allow for near complete access to utility system
components without entry into the animal facility. Others may limit maintenance access
to less sensitive areas of the animal facility such as corridors. The selected approach
shall consider tolerance of the specific program to maintenance activities, operational
effectiveness of utility access, and life cycle costs.
322
Utility Distribution Strategies
323
324
325
326
327
b) Redundancy: HVAC systems serving animal facilities shall be designed with redundant
components or standby equipment with the capability to ensure continuous operation
during equipment failure, power outages, and maintenance outages. The degree to
which the facility must remain partially or fully operational shall be established by the
Page 9
NIH Design Requirements Manual
Section 2.3
November 27, 2012 Draft
328
329
planning team during the programming phase. At a minimum, all areas of the facility that
house animals or support animal procedures shall be capable of ongoing operation.
330
331
332
333
c) Spare Capacity: Reserve capacity shall be designed into the primary building utility
systems including vertical shafts to accommodate future growth and change. Spare
capacity shall be designed into the building systems to allow flexibility to add equipment
and instrumentation as required.
334
335
d) Segregated Systems: Systems serving the vivarium shall be largely isolated from nonvivarium building systems to minimize operational fluctuations.
336
337
338
e) Directional Airflow: The HVAC system shall be capable of providing directional airflow
from more contaminated towards less contaminated areas of the facility to effectively
meet the contamination control strategy.
339
<LINK TO ENGINEERING SECTIONS>
340
2.3.4
341
342
343
344
345
346
347
348
349
350
351
352
The objective of security in an animal research facility is to ensure the safety and security of the
staff, animals, equipment, biological agents, and data. At NIH owned or leased facilities; the
site is the first level of security. The site may be open to the public or it may have controlled
access depending on the location. The second level of security is the building. Access to the
building must be managed. Air intakes and any central utilities must be safeguarded from
intruders. The third level of security is the access to the animal research facility. Administrative
staff, research and veterinary staff, maintenance staff and vendors will require access to the
animal research facility. A controlled point of entry is required prior to entering the vivarium.
Security features must also be provided for the loading docks and service entries for the animal
facility. The fourth level of security is the specific animal rooms, containment suites, surgical
suites, pharmacy, or other areas within the facility that require a higher level of controlled
access and surveillance. Security requirements shall be coordinate with DPSM.
353
Security
<LINK TO SECURITY / BIOSECURITY>
354
2.3.5 Biological Risk Assessment and Biosafety Level Criteria
355
Refer to section 2.1.3.7 and the following:
356
357
358
359
Animal biosafety levels are designated in ascending order from ABSL-1 to ABSL-4. All animal
facilities designed for the NIH shall be designed to Animal Biosafety Level 2 (ABSL-2) standards
(minimum) in accordance with the latest edition of the BMBL (Biosafety in Microbiological and
Biomedical Laboratories). (LINK).
360
2.3.6 Design Considerations
361
Refer to section 2.1.3.6.
362
2.3.6.1 Animal Holding Rooms
363
There are several factors affecting animal holding room design:
Page 10
NIH Design Requirements Manual
Section 2.3
November 27, 2012 Draft
364
365
366
367
368
369
370
371
372
373
a) Holding Room Population: The size of holding rooms is determined by the species,
number of cages or cage racks and accessory equipment per room. Larger rooms are
more efficient in terms of SF/cage; however, they increase the risk of infection of larger
numbers of animals in the event of infection outbreak, and may also require multiple
studies to be conducted within one space. There are ergonomic considerations as well,
including the number of cages that can be reasonably managed by a single caretaker
that may need to regown when entering different holding rooms, and space clearances
required to safely perform caretaking activities and procedures. Holding room sizes must
be determined by the full planning team.
374
375
376
377
378
379
380
381
382
383
b) Caging Types: The guide provides species-specific data on minimum floor area and
volumetric requirements for caging. Caging may be fixed for larger species, or freestanding racks housing multiple cages. Sufficient clearance must be provided to care for
and observe the animals, move carts and equipment around the room, and egress from
the room. Space for feed storage bins, waste container, cage change equipment, and
hand wash sinks must be accounted for. If crash rails are used within holding rooms to
protect walls or anchor cages, they must be accounted for in space calculations. Utility
systems must coordinated with caging requirements in terms of effective cooling, air
distribution, lighting and connections for specialized caging systems that may require
power and exhaust connections.
384
385
386
387
c) Species Separation: Different species often cannot be housed within the same holding
room due to different environmental requirements or other incompatibilities such as
predator-prey considerations. In facilities that serve both small and large animals
populations, the two should be segregated.
388
389
390
391
392
d) Barrier Suites: When animal facilities house both SPF and conventional (non-SPF)
animals, SPF animal holding rooms should be located within suites that are isolated from
conventional animal populations. When required by SOP, these suites should be
separated from other areas of the facility by anterooms. Dedicated autoclaves may be
required for SPF suites.
393
394
395
396
397
398
399
e) Noise and Vibration: Rodents are particularly sensitive to noise and vibration.
Background noise shall be minimized, and sudden variable noise producing elements,
such as fire alarms must be mitigated through use of strobes or voice systems. Species
that generate noise should be segregated from other animal populations. Adverse noise
may be generated by electronic devices and equipment such as occupancy sensors that
generate infrasound at frequencies undetectable to humans. Sensitivity to noise at
different frequencies also varies among species.
400
401
402
403
404
405
406
f)
407
Vibration stability is also important to maintaining a controlled environment for sensitive
animals such as rodents. Rodent holding and test rooms shall be located away from
areas such as a cage wash, mechanical rooms and elevator shafts. Vibration may not
as much of an issue for large animals except in behavior testing areas. Vibration stability
is required in areas housing specialized equipment such as imaging suites. Vibration
studies shall be performed to determine how best to achieve the maximum allowable
vibration levels as determined by instruments and animals to be used in the area.
<LINK TO STRUCTURAL VIBRATION CHART>
Page 11
NIH Design Requirements Manual
Section 2.3
November 27, 2012 Draft
408
<SUGGESTED LINK TO NIST STANDARDS>
409
410
411
2.3.6.2 Cage Wash Areas
412
413
414
415
416
417
418
419
420
421
422
423
Cage wash areas shall be buffered from animal holding and administrative support areas to
mitigate the high levels of heat, humidity, noise and vibration produced by cage wash
equipment. Design of cage wash area HVAC systems must consider the extensive heat gain
and humidity generated by cage wash equipment and procedures so that an acceptable working
environment is achieved for cage wash technicians. Clean and dirty sides of the cage wash
area are separated by a contamination control barrier to enhance environmental separation, and
facilitate airflow from the clean to the dirty side. Cage wash sanitation equipment that may
include rack washers, tunnel washer, soiled bedding disposal unit, sterilizers, etc. should be
configured for dirty-to-clean pass-through operation. When caging and materials are autoclaved
for use in SPF areas, a second pass-through sterilizer may be required between the clean cage
wash and sterile cage storage areas. The clean cage wash area equipment may include a
bedding dispenser and bottle filler.
424
425
a) Cage Wash Sizing: Factors that must be typically considered for sizing the cage wash
areas are as follows:
426
427
428
429
430
431
432
433
434
435
436
Dirty Cage Wash
 Equipment placement space including service and working clearances
 Marshaling space for racks and cages to be washed
 Prewash/soaking area for hosing or spray down of racks and caging prior to
cleaning
 Area for flushing animal drinking water manifolds, when required
 Area for queuing waste
 Area for loading carriages and component racks used in washers and
autoclaves.
 Hand wash area and commercial pot sink
 Hose station
437
438
439
440
441
442
443
444
445
446
447
448
Clean Cage Wash
 Area for wet caging to “drip-dry”, typically in front of rack washers
 Working space for preparing cages
 Area for unloading carriages and component racks used in washers and
autoclaves
 Queuing area for stacking clean caging and caging components
 Bottle filling area
 Space for clean cage marshaling or storage
 Hose station
 Compressed air system for clearing animal drinking water lines, when required
 Clean cage marshaling
Page 12
NIH Design Requirements Manual
Section 2.3
November 27, 2012 Draft
449
450
Typical Cage Wash Area Relational Diagram
451
452
Soiled
Caging
453
Waste
454
455
Waste
Clean
Caging
Tunnel Washer
Soiled
Cage Wash
Wash Down
Area
Service
Area
Rack
Washer
Waste
Feed &
Bedding
Storage
457
Sterile
Caging
Sterilizer
Autoclave
456
Clean
Cage
Waste
Storage
Clean
Cage Wash
Waste
458
459
460
461
462
463
464
465
466
b) Cage Wash Equipment: Through-put calculations shall be provided based on userprovided data and SOPs on the animal species, census, caging types, cage change
frequency, animal drinking water modes, operational schedule, staffing, redundancy
requirements, etc. to determine the type, size and quantity of equipment required for
cage sanitation and decontamination. Calculations shall be included with planning
deliverables. Equipment analysis for larger facilities shall include evaluation of the cost
effectiveness of automated systems for waste removal, cage handling and bedding
dispensing.
467
2.3.6.3 Storage
468
The following storage areas are required:
469
470
471
472
473
474
475
476
477
a) Feed Storage: Feed type is species dependant, and may include both commercial
bagged feed and prepared fresh food. Bagged feed often requires a cold room to
maintain product quality. The volume of feed that must be stored is based on the
projected consumption rate and frequency of delivery. Typically, a minimum of 2 week
supply is stored on site in a dedicated room located near the clean cage wash area;
however, more may be required for emergency contingency. Fresh feed may be
required for large animal facilities, and typically requires both refrigerated storage and
work area for preparation. The requirements for receiving, preparation and storage of
animal feed shall be determined by program personnel.
478
479
480
481
482
483
b) Bedding Storage: Bedding type is species dependant, but must also be compatible with
caging type and waste disposal methodology. The volume of bedding storage is based
on the projected consumption rate and frequency of delivery. Typically, a minimum of 2
week supply is stored on-site. Bulk, bagged bedding is stored near the clean cage wash
area. Large facilities may use automated systems that include hoppers located near the
loading dock.
Page 13
NIH Design Requirements Manual
Section 2.3
November 27, 2012 Draft
484
485
486
487
488
489
c) Cage Storage: Surplus caging and caging components are required to allow for
cleaning and change-out. Quantity is based on SOPs for frequency of cage cleaning
that determine the percentage of cages that must be cleaned on a daily basis. Typically,
this is 10%-20% of each caging type. Clean cage storage is typically located within or
adjacent to the clean cage wash area. A separate area may be required for storage of
sterilized caging and material in SPF facilities.
490
491
d) Soiled Cage Marshalling: Space shall be provided in or adjacent to the dirty cage wash
area for temporary queuing of soiled caging awaiting sanitation.
492
493
494
e) Supply Storage: Additional storage space is required for supplies, PPE, clean laundry
and other items. The location and size of this area shall be calculated with the facility
manager.
495
496
497
498
499
f)
Bulk Detergent Storage: Space is typically required for storage of bulk detergents and
disinfectants used for sanitation. Where possible, bulk detergent should be stored near
the loading dock or other area outside of the barrier to facilitate resupply, and pumped to
the point of use. The size and number of tanks required for detergent storage is a
function of delivery interval and types used, which must be determined by the program.
500
2.3.6.4 Animal Intake and Quarantine
501
502
503
504
505
506
507
508
509
Intake SOPs typically require animals to be transferred into facility standard caging and
quarantined prior to assimilation into holding rooms. This activity should be located at the
barrier perimeter, remote from clean animal populations so that potentially contaminated
animals are not transported through clean areas of the facility. Animal transfer typically requires
a biosafety cabinet or laminar flow change cabinet for handling micro-isolator caging and SPF
animals. A pass-through configuration or transfer box facilitates this procedure. Quarantine
holding rooms shall comply with the same criteria as other holding rooms. SOPs for
decontaminating quarantine caging prior to transport through interior barrier corridors must be
accommodated by the design.
510
2.3.6.5 Necropsy
511
512
513
514
515
516
517
A necropsy area may be required, particularly for large animal holding facilities. This room is
considered to be “dirty”, and should be located at the barrier perimeter, or outside of the barrier
along the waste removal pathway. Space requirements must be determined by equipment and
furnishing needs as well as working space for personnel performing autopsies and tissue
harvesting.
Animal carcasses are considered to be MPW, and require a designated cold
storage area, often adjacent to the loading dock waste area. Both refrigerator and freezer
storage are required.
518
2.3.6.6 Surgical Suites
519
520
521
522
523
524
Large animal holding facilities and some small animal holding facilities require surgical facilities.
Large animal surgical suites consist of one or more surgery rooms, a surgeon scrub area,
animal prep room, surgical supply and work room, and recovery area. Depending on SOPs,
recovery may occur within holding rooms. Small animal surgery may be performed within a
typical procedure room or designated rooms equipped with exhausted surgical stations
designed to contain biological contaminants and scavenge anesthetic gasses. Directional
Page 14
NIH Design Requirements Manual
Section 2.3
November 27, 2012 Draft
525
526
airflow is particularly critical in surgical suites to maintain aseptic conditions within the operating
room. The following diagram illustrates typical large animal surgery suite organization:
527
Surgical Suite Relational Diagram
Animals
528
529
Pass through
Cabinet
530
Animal
Waste
Recovery
Prep
531
Clean
Materials
532
533
Surgical
Supply
Waste
Sterilizer
Operatory
Waste
Waste
Staff
Waste
534
Surgeon
Scrub
535
Wast
e
536
2.3.6.7 Insectaries
537
538
539
540
541
542
543
544
545
546
Insectaries are containment suites designed to house insect research models. Guidelines for
Insectary design are provided in the Arthropod Containment Guideline, Version 3.1 published by
the American Committee of Medical Entomology and the American Society of Tropical
Medicine. Co-locating an Insectary with a mammalian holding facility must consider the risk of
disease transmission via insect vector. Functional components of insectaries typically include
environmental chambers (walk-in or cabinet type) for insect holding and breeding, procedure
room and anteroom to facilitate containment. Insectary suites shall be separated from other
vivarium areas by a vestibule with two self-closing doors. Sufficient space shall be provided for
procedures involving live insects to be performed within the suite, thereby minimizing the need
for transport of live insects.
547
2.3.6.8 Aquatics
548
549
550
551
552
553
554
555
556
557
558
559
560
Aquatic holding rooms require special planning to support their unique environmental
requirements and engineering systems. They are wet areas that require drainage systems,
generate humidity and can adversely affect surrounding areas. Environmental criteria differ
depending on species housed and aquatic water system specification, and must be established
with user consultation. Aquatic holding racks require water filtration and treatment systems that
may be self-contained or require dedicated equipment space. It is important to note that the
aquatic water system forms the animal microenvironment and must be specified to meet
research and animal husbandry parameters for biological filtration, temperature, flow rate,
purity, pH, particulates, salinity, and oxygenation. Aquatic support areas may include procedure
rooms for microinjection and mutagenesis, brine shrimp hatcheries, and wash areas that are
separated from other cage wash areas to prevent detergents and disinfectants from
contaminating the aquaria. Some aquatic water systems utilize gravity drainage that requires
lower level water filtration systems.
561
2.3.6.9 Animal Imaging
Page 15
NIH Design Requirements Manual
Section 2.3
November 27, 2012 Draft
562
563
564
565
566
567
568
569
570
571
572
Advanced imaging suites utilizing various modalities including MRI, PET, CT, ultrasound, and
bioluminescence are becoming increasingly critical for animal based research. Facilities for
animal imaging must typically meet criteria equivalent to similar facility for humans, except that
equipment size is often smaller, especially for small animals. Imaging suites may be core
facilities serving both resident animals as well as animals from other facilities. Imaging suites
typically include imaging rooms, imaging support equipment rooms, animal prep, holding and
procedure space, and space for equipment control consoles. Space size and configuration
must comply with imaging equipment manufacturer field installation criteria and accepted by
manufacturer representatives. Spatial relationships must facilitate user defined work flow and
SOPs for animal handling. Location of animal imaging facilities should take the following issues
into consideration:
573
574

Vibration stability and isolation from vibration sources required meet equipment
operating criteria.
575

Structural capability to accommodate equipment weight
576
577
578

Isolation from sources of interference. For MRIs this may include separation
and/or shielded from large moving ferrous metal objects (vehicles, elevators) that
distort data output.
579
580

Isolation for personnel safety. For MRIs, areas within the 5 gauss magnetic field
must be secured to exclude people.
581

Pathway for delivery and installation of large, heavy equipment components
582
583
584

Equipment components that are not required to be within the same room as the
animal should be located outside of the barrier to the greatest extent possible to
facilitate maintenance access.
585
586
587

Transport of animals to and from the facility. If the facility serves as a core that
images animals from outside sources, transport and handling of potentially “dirty”
animals must also be considered.
588
2.3.6.10 Behavioral Suites
589
590
Behavioral suites and procedure rooms shall be located remotely from sources of noise and
vibration such as cage wash areas and large animal holding rooms.
591
2.3.7 Planning and Programming Deliverables
592
593
Refer to Section 2.1.3 for predesign deliverable requirements. Additions to this list are as
follows:
594
595
596
597
598
599



Flow diagrams indicating proposed circulation of animals, staff, caging sanitation, waste,
and materials based on SOPs listed in Section 2.3.2.2.
Projects including sanitation or decontamination equipment shall include through-put
calculations validating that the equipment is properly sized
ARF Questionnaire (link)
Page 16
NIH Design Requirements Manual
Section 2.3
November 27, 2012 Draft
600
Animal Research Facility - Program Questionnaire
601
602
603
The purpose of this questionnaire is to obtain information from the customer that is necessary to
produce the Program of Requirements (POR) for BSL2 research animal facilities. Other
questionnaires are provided for Laboratories and ABSL-3 facilities.
604
1
General Requirements
605
1.1
List all of the Institutes / Centers to be accommodated in this space.
606
1.2
Identify project stakeholders and responsibilities
607
1.3
Identify Facility Manager
608
1.4
Identify Safety Officer
609
1.5
Identify the point of contacts and their roles.
610
1.6
Identify all staff and occupants anticipated to be within this space.
611
1.7
Identify roles of all staff.
612
2
Program Requirements
613
2.1
Describe project objectives including schedule and budget
614
2.2
Identify the assigned sq. ft. for the project.
615
616
2.3
Identify office, administrative, conference/training and personnel functions to be
provided.
617
618
2.4
Are lockers, showers, toilet rooms required? Separate Men’s and Women’s
facilities? Pass-through design?
619
2.5
List attributes and deficiencies of your current facility.
620
2.6
Identify material storage requirements.
621
2.7
Identify need for personnel lockers.
622
2.8
Identify need for Janitor Closets.
623
3
Functional Relationships
624
3.1
Describe functional relationships among program components (use matrix provided)
625
3.2
Identify preferred location of offices and tech areas.
626
4
Animal Holding & Caging
627
4.1
Identify each population of animals to be housed (species, number, health status)
628
4.2
Identify types of caging to be used for each group (existing and new)
629
4.3
Identify required separation among groups, and need for barrier suites
630
631
4.4
Identify animal holding room requirements for each group (features, drains, sinks,
cages/room, equipment, environmental requirements, etc.)
632
4.5
Identify sanitation procedure and schedule for each animal group
633
4.6
Identify animal intake and quarantine holding requirements
Page 17
NIH Design Requirements Manual
Section 2.3
November 27, 2012 Draft
634
5
Procedure Space
635
636
5.1
Describe types and sizes of desired procedure rooms, and required proximity to
animal holding areas.
637
5.2
Is a necropsy room needed?
638
5.3
Are there any advanced imaging areas required?
639
640
5.4
Other specialized areas (gamma cell, aquatics, surgical facilities, isolation rooms,
rederivation, etc.)
641
6
Standard Operating Procedures
642
4.1
Describe desired personnel, material and waste flow through the facility.
643
4.2
Identify desired security hierarchy and special security requirements.
644
645
4.3
Identify PPE and gowning requirements and entry / exiting procedures for different
areas of the facility
646
647
4.4
Identify delivery schedule and storage requirements for feed, bedding and other
materials
648
649
4.5
Describe decontamination procedures and sterilization requirements (waste, space,
caging, animal carcasses and material).
650
651
652
4.6
4.7
4.8
Identify security protocols
Identify emergency management procedures
Will laundry be used and/or cleaned on site?
653
5
Cage Processing SOPs
654
5.1
Identify cage change schedule for each caging type
655
5.2
Identify decontamination and sanitation procedure for each caging type
656
5.3
Identify bedding waste disposal SOP
657
658
5.4
Identify desired sanitation and sterilization equipment, including minimum chamber
or belt sizes, if known.
659
6
Design Parameters
660
6.1 Identify proposed biosafety level(s).
661
662
6.2 Identify environmental parameters for each animal housing group (temperature,
humidity, air change rate, lighting)
663
6.3 List sustainability objectives and features desired for this project.
664
665
6.4 List Hazardous materials (chemical and radiological) to be used and stored within the
project area (use Chemical Inventory template for collecting this information <LINK>)
666
6.5 Identify any special noise or vibration restrictions.
667
668
669
7
Technical Requirements
7.1
Complete Room Data Sheet for each type of desired space. (use Room Data Sheet
template <LINK>)
Page 18
NIH Design Requirements Manual
Section 2.3
November 27, 2012 Draft
670
671
7.2
List required services (i.e. CO2, O2, Vacuum, Compressed Air, etc.) and location
required (use room data sheets)
672
7.3
Identify animal drinking water requirements and distribution approach
673
7.4
Identify sink, eyewash fountain and deluge shower requirements (room data sheets)
674
7.5
Casework: identify type and location (use room data sheets)
675
7.6
Identify any special signage or program identification requirements.
676
7.7
Identify drain and floor sloping requirements (room data sheets)
677
7.8
Identify desired noise limitations for alarm systems
678
7.9
Identify minimum door sizes
679
7.10 Identify minimum ceiling heights
680
7.11 Identify requirements for environmental monitoring
681
7.12 Special communication requirements (intercom, WiFi, etc.)
682
8
Equipment Requirements
683
684
8.1
Identify all existing and new vivarium equipment to be housed within this space (use
equipment schedule template for collecting this info <link >)
685
8.2
Provide equipment data sheets for existing and proposed equipment.
686
687
8.3
Identify equipment items that require unusual or excessive clearances, structural
support, headroom, vibration control, sound isolation, or other physical features.
688
9
Proposed Project Site
689
9.1
Identify the proposed project location.
690
691
9.2
For renovations, identify physical condition and known spatial and infrastructure
deficiencies.
692
693
9.3
Identify and/or provide any available documentation for current and proposed space.
Page 19